483
Octapharma S.A.S.FDA 483 - Octapharma S.A.S.
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Record Details
Octapharma S.A.S. in Lingolsheim, France, a drug substance and drug product manufacturer, received a Form 483 with two observations. The inspection found deficiencies in the validation of disinfecting agents, specifically regarding their efficacy against spore-forming organisms. Additionally, production equipment was not maintained in a state of good repair, with corrosion observed and a lack of preventive maintenance.
- Company
- Octapharma S.A.S.
- Product Type
- Drugs
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ID · fa8968b0-01e3-436f-87c4-bace15c05962